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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383319
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
Bd received two (2) representative units for evaluation from the customer in support of this complaint. Our quality engineer visually inspected the returned units and was unable to identify any damage to any of the units' components. Leak testing was then performed and no leakage was observed throughout the devices. We were unable to determine a root cause for this occurrence based on the provided samples. Bd was unable to confirm the reported defect by customer. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: unable to determine a root cause.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7083688, medical device expiration date: 2021-03-31, device manufacture date: 2017-04-26, medical device lot #: 7083688, medical device expiration date: 2020-09-30, device manufacture date: 2016-09-14.
 
Event Description
It was reported that during use of a bd saf-t-intima iv catheter safety system, it was found leaking. The ¿catheters seem to have a hole or to be cut. ¿ there was no report of injury or medical intervention needed.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7135919
MDR Text Key269554906
Report Number9610847-2017-00196
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383319
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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